【奥译言】加拿大卫生部提议简化医疗器械优先审查程序

2018-11-29 09:33 阅读数：3984 标签：

背景

医疗器械上市许可申请通常按照加拿大卫生部医疗器械局（Medical Devices Bureau）接收的顺序进行处理和审查。

然而，根据2000年发布的《医疗器械上市许可申请优先审查暂行政策》，在有大量临床证据表明某种用于诊断或治疗危及生命或严重衰竭性疾病或病症的III类或IV类医疗器械能够满足以下要求时，将对该医疗器械的上市许可申请实行优先审查制度：

•能够有效治疗或诊断某种疾病或病症，而加拿大境内目前没有任何可用于治疗或诊断该疾病或病症的医疗器械获得上市许可；或者，

•在加拿大上市销售的现有的治疗或诊断医疗器械无法实现对某种疾病或病症的相应治疗或诊断目的，相比之下，该医疗器械的风险受益比显著改善。

《医疗器械上市许可申请优先审查暂行政策》审查

加拿大卫生部（Health Canada）结合加拿大政府现代化监管框架的总体举措，对《医疗器械上市许可申请优先审查暂行政策》进行了审查。

加拿大卫生部得出结论认为，虽然实施该暂行政策的目的是为了让加拿大国民更快用上能够有效治疗或诊断一些危及生命或严重衰竭性疾病或病症的新医疗器械，但现行的优先审查程序未免过于复杂。加拿大卫生部还表示，在授予优先审查资格时，应考虑到不可预见的或尚未满足的紧急卫生需求（例如发生流行病）。

拟议修改优先审查请求和资格标准的行政程序

为了简化优先审查程序，加拿大卫生部打算在新修订的医疗器械上市许可申请表中纳入优先审查请求选项——不再需要另行提交申请表。

当有大量临床证据表明某种用于治疗或诊断危及生命或严重衰竭性疾病或病症的III类或IV类医疗器械能够满足以下要求时，将授予该医疗器械上市许可优先审查资格：

•能够有效治疗或诊断某种疾病或病症，而加拿大境内目前没有任何可用于治疗或诊断该疾病或病症的医疗器械获得上市许可；

•在加拿大上市销售的现有的治疗或诊断医疗器械无法实现对某种疾病或病症的相应治疗或诊断目的，相比之下，该医疗器械的风险收益比显著改善；或者，

•能够满足不可预见的或尚未满足的紧急卫生需求。（新增）

当局会在收到优先审查申请后15天内对其进行行政完整性和申请确认的筛查，但若满足以上标准，可获得优先审查资格。根据优先审查申请的复杂程度或产品的创新性，可能会缩短产品上市周期，但最终将实行III类或IV类医疗器械的上市许可申请审查的现行费用和服务标准（即60天或75天）。此外，当局会在筛查时告知申请人其优先审查申请是否予以受理。

英文原文

Notice of Intent – Health Canada to confirm its priority review request process of medical device applications and eligibility criteria

Context

Medical devices applications are generally processed and reviewed in the order they are received by the Medical Devices Bureau (MDB).

However, under the Interim Policy on Priority Review of Medical Device Licence Application issued in 2000, a preferential prioritization system was introduced for the review of some Class III or IV medical device licence applications intended for the diagnosis or treatment of a serious, life-threatening or severely debilitating disease or condition when there is substantial clinical evidence that the medical device provides:

•Effective treatment or diagnosis of a disease or condition for which no medical device is currently licenced in Canada; or

•Significant risk-benefit improvement over existing therapeutic or diagnostic devices for a disease or condition that is not adequately managed by existing products marketed in Canada.

Review of the Interim Policy on Priority Review of Medical Device Licence Applications

Health Canada has reviewed the Interim Policy on Priority Review of Medical Device Licence Applications in the context of the overall government’s initiative to modernize Canada’s regulatory framework.

Health Canada concluded that while the intent of the interim policy, to provide faster access for Canadians to new medical devices for serious, life-threatening or severely debilitating diseases or conditions is still relevant, the existing request process is unnecessarily complex. Health Canada also acknowledges that consideration should be given to unforeseen or unmet urgent health need (e.g. in the context of a pandemic) in granting priority review.

Proposed changes to the administrative process for requesting priority review and eligibility criteria

In order to streamline the priority review request process, Health Canada intends to incorporate a priority review request option in the new and amendment medical device licence application forms - there will no longer be a requirement for a separate request/form.

Priority review will be granted to a Class III or IV medical device licence applications intended for the diagnosis or treatment of a serious, life-threatening or severely debilitating disease or condition when there is substantial clinical evidence that the medical device:

•Provides effective treatment or diagnosis of a disease or condition for which no medical device is currently licenced in Canada;

•Provides significant risk-benefit improvement over existing therapeutic or diagnostic devices for a disease or condition that is not adequately managed by existing products marketed in Canada; or,

•Responds to an unforeseen or unmet urgent health need. (New)

Applications requesting priority review will be screened in accordance with the standard 15 day performance target, but reviewed in priority when meeting the above criteria. Depending on the complexity of the application or the novelty of the product, this might lead to a shorter time to market, but ultimately the existing fees and service standards for review of Class III and IV licence applications will apply (i.e. 60 and 75 days). Applicants will be notified at screening acceptance whether their application was accepted for priority review.

内容来自：Health Canada

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